FDA.reportPublic FDA data

Doxazosin

Product NDC
50090-0701
11-digit product format
500900701
Labeler code
50090
Product ID
50090-0701_3fba2a6d-a770-467a-b7a5-5a1f33e5f662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxazosin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075580
Marketing category
ANDA
Marketing start
2011-07-14
Substance
DOXAZOSIN MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Doxazosin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXAZOSIN MESYLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii86P6PQK0MU
Rxcui197625, 197626, 197627, 197628

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07a517fc-5845-3816-0f81-0a121804ec9eProduct name620250107
171dd63c-7eea-ede4-c010-4c25ba0a1087Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0701-02023-02-07C16284748780-1f386c649-c84b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990
50090-0701-02023-01-30C16284748780-1f386c649-c84b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use DOXAZOSIN TABLETS safely and effectively. See full prescribing information for DOXAZOSIN TABLETS. DOXAZOSIN tablets, for oral use Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0701-0Doxazosin30 in 1 BOTTLETABLET3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0701-0EA - Each50090-0701fc58bb48-b4d3-469e-a666-89182184246912018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0701DOXAZOSIN TABLET [A-S MEDICATION SOLUTIONS]28Current NDC, Legacy NDC, 1 package rows20240615_bfea0b5b-9354-490f-88ff-008134077d24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197625doxazosin mesylate 1 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin mesylate 2 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin mesylate 4 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin mesylate 8 MG Oral TabletPSNbfea0b5b-9354-490f-88ff-008134077d2430
197625doxazosin 1 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin 2 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin 4 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin 8 MG Oral TabletSCDbfea0b5b-9354-490f-88ff-008134077d2430
197625doxazosin (as doxazosin mesylate) 1 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197626doxazosin (as doxazosin mesylate) 2 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197627doxazosin (as doxazosin mesylate) 4 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430
197628doxazosin (as doxazosin mesylate) 8 MG Oral TabletSYbfea0b5b-9354-490f-88ff-008134077d2430

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0701-05009007010030 TABLET in 1 BOTTLE (50090-0701-0) 30 tablet2014-11-280000-00-00NoNoCurrent